Thera-Turn CM-1000 Mattress Overlay System
FDA 510(k) K931594 · Medical Device Inspection Co., Inc.
510(k) numberK931594
Submission
- Device name
- Thera-Turn CM-1000 Mattress Overlay System
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- March 31, 1993
- Decision date
- December 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
Other 510(k)s with product code IOQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | Hill-Rom | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | Hill-Rom | 06/03/2013SE |
| K973624 | Nurse's Aid Patient Rotation SystemIOQ · Traditional | Air Med Assist Products | 01/21/1998SE |
| K970364 | AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970363 | Hydrotec Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | Hill-Rom, Inc. | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | Hill-Rom, Inc. | 07/03/1997SE |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | Hill-Rom, Inc. | 05/16/1997SE |
| K943433 | Total Contact Seat Ripple SystemIOQ · Traditional | Numotech, Inc. | 07/31/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | Hill-Rom, Inc. | 06/27/1995SE |
More from Hill-Rom, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945826 | J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software…HCC · Traditional | 08/04/1995SE |
| K932072 | Jarit Surgical InstrumentsHET · Traditional | 01/11/1994SE |
| K933581 | Powermatic Treatment TableINQ · Traditional | 11/05/1993SE |
| K933580 | Power Work TableINQ · Traditional | 11/05/1993SE |
| K933578 | Powermatic Mat PlatformINQ · Traditional | 11/05/1993SE |
| K933577 | Powermatic Examination TableINQ · Traditional | 09/30/1993SE |
| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
| K912075 | C-Section TrayKNA · Traditional | 04/07/1992SESK |
| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
| K920403 | Xenon Arc Endoscope Light SourceGCJ · Traditional | 02/21/1992SE |
Questions and answers
When was Thera-Turn CM-1000 Mattress Overlay System cleared by the FDA?
Thera-Turn CM-1000 Mattress Overlay System (K931594) received a 510(k) decision of Substantially Equivalent on December 21, 1993, 265 days after the submission was received.
What is the product code of K931594?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.